A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involve accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.
Traditionally, external pressure is applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface but may be unsuitable for patients with substantial amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.
There are several prior art devices that try to overcome the disadvantages of the traditional external pressure application. For example, there are devices that place a hemostat within the bloodstream of the vessel, within the wall of the blood vessel, or adjacent to the wall of the blood vessel puncture site to close the puncture. However, reliance is on tactile sensation alone to indicate to the surgeon the proper placement of the puncture closing instrumentation. Other prior art references require a separate device for locating the blood vessel puncture site which is must then be removed for insertion of a second device to expel a hemostat. Still other prior art devices use bleed back ports to locate the blood vessel puncture site in conjunction with other devices such as a foot plate placed against the blood vessel wall or closure devices with anchors. However, in some of these prior art devices a surgeon is then required to use sutures and/or needles to close the blood vessel puncture. Moreover, in some of the prior art devices, external pressure applied at the surface of the skin may still be required.
Other devices utilize a dilator having a bleed back entrance port and a bleed back exit port. However, current dilators used today, as shown in FIG. 6, require the blood to traverse through a long, narrow, and often restricted lumen before exiting the bleed back exit port. This results in poor visual bleed back, which compromises the accuracy of the blood vessel puncture site as further discussed below with reference to FIG. 6. Moreover, since the blood must traverse through a long and thin lumen, the blood may quickly and easily clot further restricting the blood flow out of the bleed back exit port.
Thus, there is still a need for an apparatus and method to efficiently and easily locate a blood vessel puncture site.